Laboratory instrument/analyser application software IVD - UK MHRA Medical Device Registration

Laboratory instrument/analyser application software IVD is a medical device registered with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) under Device ID 112952. The device is manufactured by Fujirebio Europe N.V. from Belgium, classified as In Vitro Diagnostic Device. The authorized representative in the UK is Qarad UK Ltd..

This page provides comprehensive regulatory information including complete registration details, manufacturer information, device classification, authorized representative details, and related products. Pure Global AI offers free access to 150,962+ UK MHRA medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

MHRA Registered

In Vitro Diagnostic Device

🇬🇧

Laboratory instrument/analyser application software IVD

MHRA Device ID: 112952•Ref: 112952

Device Type

In Vitro Diagnostic Device

Devices

Laboratory instrument/analyser application software IVD

Type

IVD General

Date Registered

Nov 26, 2024

Last Updated

May 9, 2024

Manufacturer Information

Name

Fujirebio Europe N.V.

Address

Technologiepark 6

Gent, Oost-Vlaanderen, Belgium

Created Date

Apr 13, 2021

Authorized Representative

Name

Qarad UK Ltd.

Relationship Type

UK Responsible Person

Address

8 Northumberland Ave

Westminster, London , England, United Kingdom

Postcode: WC2N 5BY

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from Fujirebio Europe N.V. (10)

Other Products from Same Authorized Representative (10)

Laboratory instrument/analyser application software IVD - UK MHRA Medical Device Registration

Device Type

Devices

Type

Date Registered

Last Updated

Name

Address

Created Date

Name

Relationship Type

Address

DJ Fang

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, fluorescent immunoassay

Streptococcus pneumoniae antigen IVD, kit, rapid ICT, clinical

Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, fluorescent immunoassay

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Cryptosporidium species antigen IVD, kit, rapid ICT, clinical

Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical

SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Trichomonas vaginalis antigen IVD, kit, rapid ICT, clinical

D-dimer IVD, kit, fluorescent immunoassay

Tau protein IVD, kit, enzyme immunoassay (EIA)

Digital imaging scanner/reader calibration card IVD

Hepatitis C virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Human placental alkaline phosphatase (hPLAP) IVD, kit, enzyme immunoassay (EIA)

Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, enzyme immunoassay (EIA)

Laboratory instrument/analyser application software IVD

Line probe assay interpretation template IVD

Tau protein IVD, kit, enzyme immunoassay (EIA)

Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay

Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

Coagulation analyser IVD, laboratory

Adenovirus antigen IVD, kit, rapid ICT, clinical

Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical

Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

Histology/cytology/microbiology image-analysis interpretive software IVD

Nucleic acid extraction/isolation kit IVD

Activated clotting time (ACT) IVD, reagent

C-reactive protein (CRP) IVD, control